Ivermectin EP Impurity I(Mixture of Diastereomers) CAS 1135339-49-9

Description

Compared with other compounds in its class, the molecular weight of 875.09 g/mol gives Ivermectin EP Impurity I(Mixture of Diastereomers) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Ivermectin EP Impurity I(Mixture of Diastereomers) (CAS 1135339-49-9) is a certified pharmaceutical impurity reference standard with the molecular formula C48H74O14 and a molecular weight of 875.09 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system, Ivermectin EP Impurity I(Mixture of Diastereomers) is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 875.09 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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